Who we are
VI.REL Pharma was born in 1997 as consulting company in the pharmaceutical R&D sector.
Today the group is composed by VI.REL Pharma, MAH in Italy and its Division VI.REL Consulting, specialized in Regulatory Affairs Consultancy, medical writing and Pharmacovigilance.
The mission of VI.REL Pharma is the care of pharmaceutical products from their birth to diffusion into the national and international markets. In addition, our company provides services for the pharmaceutical industry focused on the attainment of Italian and European Health Authorities of medical devices and nutritional supplements. The services offered by VI.REL Pharma range from regulatory consultancy necessary for the development, provision and the safekeeping of a registration dossier, due diligence, from the dossier editing (scientific and regulatory writing) to the management of procedures during the process of approval.
The core of VI.REL Pharma is constitued by Dr Paolo Biffignandi and Dr Lorella Carletto, President and Vice-President of the Company, and by Dr Virginia Biffignandi and Dr Elisa Arnaudo.
Paolo Biffignandi is Senior Medical Writing and Scientific Director. He is the QPPV of VI.REL Pharma with the task to establish, keep and administrate the Pharmacovigilance System accordingly to a full and integrated perspective on its components and functions. As QPPV, PB is also responsible for the safety management of the products from different companies and he is the reference for Competent Authorities during daily activities and for the preparation of safety reports.
Lorella Carletto is Deputy QPPV and Regulatory Affairs Responsible of VI.REL Pharma. She is in charge of the registration dossier until the conclusion of the approval process. In VI.REL Consulting and in relation to the Pharmacovigilance Services, she coordinates the communications between Competent Authorities and the Clients and cooperates in the editing of safety documents.
Virginia Biffignandi is Safety Officer. She is in charge of the updating and maintenance of the company safety database and on the behalf of client companies. She also provides the bibliographic search on databases and indexed journals and cooperates in the collection and collation of information for the elaboration of PSURs. She is also involved in writing company’ SOPs.
Elisa Arnaudo is Document and Compliance Manager and is in charge of the organization process and of the company’s documental archive, giving expertise from her professional background in education and patients’ associations.
Scientific Director, Senior Medical Writing, QPPV
MD with Ph. Ds in Endocrinology and Pharmacology. After his graduation, he undertook academic activity at the University of Turin where was appointed assistant physician at the Chair of medical Clinics and Therapeutics of the Division of Internal Medicine at S.Luigi Hospital of Turin. In 1990, he started his career as pharmaceutical physician since the foundation of VI.REL Pharma in 1997, following the increasing request of experienced professionals in the Regulatory Affairs sector and in the clinical development from pharmaceutical companies.
Paolo Biffignandi is author of more than 160 scientific articles in Endocrinology, Internal Medicine, Diabetology, Pharmacology, and Regulatory Affairs. He participated as invited speaker to major international symposiums on the European Pharmaceutical Legislation. He is member of the most eminent European societies in the field among which AFI (www.afiscientifica.it) and SIAR (www.siar.it) in Italy and EMWA (www.emwa.org), RAPS (www.raps.org), DIA (www.diaglobal.org) and TOPRA (www.topra.org) at the international level.
He has been founder and Editor-in-Chief of the journal TOPRA Rapporteur, member of the Board of Directors of TOPRA from 2004 to 2011 and President from 2009 to 2011.
Regulatory Affairs Responsible, Deputy QPPV
She graduated in Biological Sciences. She has been Scientific Responsible for Studio Barberis, Kelemata Research Laboratory, and Delalande Laboratories of Turin.
In 1989 she was co-founder with Paolo Biffignandi of Pharmacon of which she was Vice-President and Quality Responsible.
In 1997 she founded with Paolo Biffignandi VI.REL Pharma of which she is Vice-President.
From 2005 to 2010 she has been Regulatory Affairs Consultant for Procemsa Farmaceutici.
As a consultant, she worked for the main pharmaceutical companies in Italy and abroad. Since 2010, she is member of AFI and since 2012, she is part of the Pharmacovigilance Working Group at Farmindustria. In 2016, she joined the subgroup for Inspections. She is member of SFFA.
She graduated in Biological Sciences. After that, she undertook educational courses in Pharmacovigilance organized by SIAR, EMA, TEMAS and Farmindustria. Virginia works for VI.REL Pharma since 2014 as Safety Officer.
After obtaining a PhD in Science, Technology and Humanities with a dissertation on pain and medicine, Elisa Arnaudo worked in the field of research, communication in the field of pain therapy. In 2016 she started her collaboration with VI.REL Pharma in the sector of the operative management and as Document and Compliance Responsible.